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Activity & Safety Study of KX2-391 Ointment in Participants With Actinic Keratosis on the Face or Scalp

Primary Purpose

Actinic Keratosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
50 mg of KX2-391 Ointment 1%
50 mg of KX2-391 Ointment 1%
Sponsored by
Almirall, S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Males and females ≥18 years old
  2. Clinical diagnosis of stable, clinically typical actinic keratosis
  3. A define treatment area on the face or scalp
  4. Females must be postmenopausal, surgically sterile or otherwise incapable of pregnancy for at least 1 year; or must be using highly effective contraception for at least 90 days prior to treatment with KX2-391 Ointment
  5. Males who have not had a vasectomy must agree to use barrier contraception
  6. Participants who in the judgment of the Investigator, are in good general health
  7. Willing to avoid excessive sun exposure
  8. Able to comprehend and are willing to sign an informed consent form (ICF)

Exclusion Criteria:

  1. Clinically atypical and/or rapidly changing AK lesions on the treatment area
  2. Malignancy within 5 years prior to Screening except basal or squamous cell carcinoma not on the treatment area that were treated with curative intent and are without recurrence
  3. Used any of retinoids at the most 90 days before Visit 1 glucocorticosteroids and methotrexate or other anti-metabolites within, at the most 28 days, before Visit 1
  4. Used any topical therapies, treatments, or surgical or destructive modalities on the treatment area within, at the most 90 days, before Visit 1
  5. Currently, or has experienced cutaneous malignancy, sunburn or body art on the treatment area within, at the most 180 days, before Visit 1
  6. A history of sensitivity and/or allergy to any of the ingredients in the study medication
  7. A skin disease or condition that, in the opinion of the Investigator, might interfere with the study conduct or evaluations, or which exposes the participant to an unacceptable risk by study participation
  8. Other significant uncontrolled or unstable medical diseases or conditions that, in the opinion of the Investigator, would expose the participant to unacceptable risk by study participation
  9. Females who are pregnant or nursing
  10. Participated in an investigational drug trial during which an investigational study medication was administered within 14 days or 5 half-lives of the investigational product, whichever is longer, before dosing.

Sites / Locations

  • Center for Dermatology Clinical Research
  • eStudy Site
  • Palmtree Clinical Research, Inc.
  • Horizons Clinical Research Center
  • Clinical Research of South Florida
  • International Dermatology Research
  • Compass Research
  • Forward Clinical Trials, Inc.
  • Palm Beach Research Center
  • Minnesota Clinical Study Center
  • Dermatology and Laser Center of Charleston
  • Institute of Clinical Research - Tennessee, LLC
  • J&S Studies, Inc.
  • The Center for Skin Research
  • Clinical Trials of Texas, Inc.
  • Dermatology Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

KX2-391 50 mg (Days 1 to 5)

KX2-391 50 mg (Days 1 to 3)

Arm Description

Participants were applied 50 milligrams (mg) of KX2-391 Ointment 1% topically on face or scalp in 25 centimeter square (cm^2) treatment area, once daily for 5 consecutive days.

Participants were applied 50 mg of KX2-391 Ointment 1% topically on face or scalp in 25 cm^2 treatment area, once daily for 3 consecutive days.

Outcomes

Primary Outcome Measures

Percentage of Participants With Complete Response of Actinic Keratosis
Complete response rate was defined as the percentage of participants achieving 100% clearance in the treatment area on the face or scalp at Day 57.

Secondary Outcome Measures

Percentage of Participants With Partial Response of Actinic Keratosis
Partial response rate was defined as the percentage of participants achieving more than or equal to 75% clearance in the treatment area on the face or scalp at Day 57.
Overall Change From Baseline in Actinic Keratosis Lesion Counts at Day 8, 15, 29 and 57
Overall changes from baseline in actinic keratosis lesion counts has been reported.
Number of Participants With Any Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational Product (IP). An AE did not necessarily have a causal relationship with the medicinal product. An SAE was defined as any untoward medical occurrence that at any dose, resulted in death, was life-threatening (i.e, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). TEAEs were defined as either those AEs with an onset after dosing or those pre-existing conditions that worsened after dosing. TEAEs included both serious and non-serious TEAEs.
Number of Participants With Any Treatment-emergent Adverse Events During Recurrence Follow-up Period
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an IP. An AE did not necessarily have a causal relationship with the medicinal product. An SAE was defined as any untoward medical occurrence that at any dose, resulted in death, was life-threatening (i.e, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). TEAEs were defined as either those AEs with an onset after dosing or those pre-existing conditions that worsened after dosing. TEAEs included both serious and non-serious TEAEs.
Number of Participants With Maximal Post Baseline Local Skin Reactions (LSRs)
Maximal post baseline LSR was defined as the highest grade of any LSR reported at any post baseline visits for a participant. Local skin reactions assessment included signs of erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration on the treatment area. These signs were assessed using a 5-point grading scale ranging from 0 (not present) to 4 (worst), where (grade 0 = absent, grade 1 = slight, grade 2 = moderate, grade 3 = severe, grade 4 = very severe).
Number of Participants With Clinically Significant Abnormalities in Laboratory
Laboratory parameters included hematology, blood chemistry and urinalysis. Clinical significance was determined by the investigator.
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Vital signs included measurement of pulse rate, systolic and diastolic blood pressure, respiratory rate, and body temperature. Clinical significance was determined by the investigator.
Number of Participants With Clinically Significant Abnormalities in Electrocardiograms (ECGs)
ECG parameters included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals and corrected QT (QTc) intervals. Clinical significance was determined by the investigator.
Number of Participants With Clinically Significant Abnormalities in Physical Examination (PE)
A physical examination included weight and height measurements was performed. Clinical significance was determined by the investigator.
Maximum Observed Plasma Concentration (Cmax) of KX2-391 of KX2-391
Cmax was defined as the maximum observed plasma concentration obtained directly from the concentration versus time curve.
Area Under the Plasma Concentration Time Curve From Time 0 to the Last Sampling Time (AUCt) of KX2-391
Area under the plasma concentration versus time curve from time zero to the last sampling time (t) at which the concentration is at or above the LLOQ. AUC(0-t) was calculated according to the mixed log-linear trapezoidal rule.
Minimum Observed Plasma Concentration (Cmin) of KX2-391
Cmin was defined as minimum observed plasma concentration obtained directly from the concentration versus time curve.
Accumulation Ratio (R)
Ratio calculated from AUC and Cmax found on the last day of treatment and Day 1.

Full Information

First Posted
July 18, 2016
Last Updated
March 19, 2021
Sponsor
Almirall, S.A.
Collaborators
Athenex, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02838628
Brief Title
Activity & Safety Study of KX2-391 Ointment in Participants With Actinic Keratosis on the Face or Scalp
Official Title
A Phase 2a, Open-Label, Multicenter, Activity and Safety Study of KX2-391 Ointment 1% in Subjects With Actinic Keratosis on the Face or Scalp
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 11, 2016 (Actual)
Primary Completion Date
January 11, 2017 (Actual)
Study Completion Date
December 22, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Almirall, S.A.
Collaborators
Athenex, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In this study, the activity, safety, and pharmacokinetics (PK) of KX2-391 Ointment was evaluated in adult participants with a clinical diagnosis of stable, clinically typical actinic keratosis (AK) on the face or scalp.
Detailed Description
This study was an open-label, multicenter, activity, safety, tolerability, and PK study of KX2-391 Ointment administered topically to the face or scalp of participants with AK. The study consists of Screening, Treatment, and Follow-up Periods. Eligible participants were received 3 or 5 consecutive days of topical treatment, applied at the study site. Blood samples for PK analysis were collected. Activity (lesion counts) and safety evaluations were performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KX2-391 50 mg (Days 1 to 5)
Arm Type
Experimental
Arm Description
Participants were applied 50 milligrams (mg) of KX2-391 Ointment 1% topically on face or scalp in 25 centimeter square (cm^2) treatment area, once daily for 5 consecutive days.
Arm Title
KX2-391 50 mg (Days 1 to 3)
Arm Type
Experimental
Arm Description
Participants were applied 50 mg of KX2-391 Ointment 1% topically on face or scalp in 25 cm^2 treatment area, once daily for 3 consecutive days.
Intervention Type
Drug
Intervention Name(s)
50 mg of KX2-391 Ointment 1%
Intervention Description
Dose: 50 mg; Route of administration: Topical
Intervention Type
Drug
Intervention Name(s)
50 mg of KX2-391 Ointment 1%
Intervention Description
Dose: 50 mg; Route of administration: Topical
Primary Outcome Measure Information:
Title
Percentage of Participants With Complete Response of Actinic Keratosis
Description
Complete response rate was defined as the percentage of participants achieving 100% clearance in the treatment area on the face or scalp at Day 57.
Time Frame
Day 57
Secondary Outcome Measure Information:
Title
Percentage of Participants With Partial Response of Actinic Keratosis
Description
Partial response rate was defined as the percentage of participants achieving more than or equal to 75% clearance in the treatment area on the face or scalp at Day 57.
Time Frame
Day 57
Title
Overall Change From Baseline in Actinic Keratosis Lesion Counts at Day 8, 15, 29 and 57
Description
Overall changes from baseline in actinic keratosis lesion counts has been reported.
Time Frame
Baseline, Days 8, 15, 29 and 57
Title
Number of Participants With Any Treatment-emergent Adverse Events (TEAEs)
Description
An adverse event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an investigational Product (IP). An AE did not necessarily have a causal relationship with the medicinal product. An SAE was defined as any untoward medical occurrence that at any dose, resulted in death, was life-threatening (i.e, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). TEAEs were defined as either those AEs with an onset after dosing or those pre-existing conditions that worsened after dosing. TEAEs included both serious and non-serious TEAEs.
Time Frame
Baseline up to Day 57 (Treatment and follow-up period)
Title
Number of Participants With Any Treatment-emergent Adverse Events During Recurrence Follow-up Period
Description
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered an IP. An AE did not necessarily have a causal relationship with the medicinal product. An SAE was defined as any untoward medical occurrence that at any dose, resulted in death, was life-threatening (i.e, the participant was at immediate risk of death from the AE as it occurred; this did not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death), required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). TEAEs were defined as either those AEs with an onset after dosing or those pre-existing conditions that worsened after dosing. TEAEs included both serious and non-serious TEAEs.
Time Frame
From Day 57 up to 12-months post-Day 57 (Recurrence follow-up period)
Title
Number of Participants With Maximal Post Baseline Local Skin Reactions (LSRs)
Description
Maximal post baseline LSR was defined as the highest grade of any LSR reported at any post baseline visits for a participant. Local skin reactions assessment included signs of erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration on the treatment area. These signs were assessed using a 5-point grading scale ranging from 0 (not present) to 4 (worst), where (grade 0 = absent, grade 1 = slight, grade 2 = moderate, grade 3 = severe, grade 4 = very severe).
Time Frame
Day 57
Title
Number of Participants With Clinically Significant Abnormalities in Laboratory
Description
Laboratory parameters included hematology, blood chemistry and urinalysis. Clinical significance was determined by the investigator.
Time Frame
Baseline to Day 57
Title
Number of Participants With Clinically Significant Abnormalities in Vital Signs
Description
Vital signs included measurement of pulse rate, systolic and diastolic blood pressure, respiratory rate, and body temperature. Clinical significance was determined by the investigator.
Time Frame
Baseline up to Day 57
Title
Number of Participants With Clinically Significant Abnormalities in Electrocardiograms (ECGs)
Description
ECG parameters included heart rhythm, heart rate, QRS intervals, QT intervals, RR intervals and corrected QT (QTc) intervals. Clinical significance was determined by the investigator.
Time Frame
Baseline up to Day 57
Title
Number of Participants With Clinically Significant Abnormalities in Physical Examination (PE)
Description
A physical examination included weight and height measurements was performed. Clinical significance was determined by the investigator.
Time Frame
Baseline up to Day 57
Title
Maximum Observed Plasma Concentration (Cmax) of KX2-391 of KX2-391
Description
Cmax was defined as the maximum observed plasma concentration obtained directly from the concentration versus time curve.
Time Frame
Pre-dose, 0.5, 1 and 4 hours post-dose on Days 1, 3 (Cohort 2) and 5 (Cohort 1)
Title
Area Under the Plasma Concentration Time Curve From Time 0 to the Last Sampling Time (AUCt) of KX2-391
Description
Area under the plasma concentration versus time curve from time zero to the last sampling time (t) at which the concentration is at or above the LLOQ. AUC(0-t) was calculated according to the mixed log-linear trapezoidal rule.
Time Frame
Pre-dose, 0.5, 1 and 4 hours post-dose on Days 1, 3 (Cohort 2) and 5 (Cohort 1)
Title
Minimum Observed Plasma Concentration (Cmin) of KX2-391
Description
Cmin was defined as minimum observed plasma concentration obtained directly from the concentration versus time curve.
Time Frame
Pre-dose, 0.5, 1 and 4 hours post-dose on Days 1, 3 (Cohort 2) and 5 (Cohort 1)
Title
Accumulation Ratio (R)
Description
Ratio calculated from AUC and Cmax found on the last day of treatment and Day 1.
Time Frame
Pre-dose, 0.5, 1 and 4 hours post-dose on Days 1, 3 (Cohort 2) and 5 (Cohort 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females ≥18 years old Clinical diagnosis of stable, clinically typical actinic keratosis A define treatment area on the face or scalp Females must be postmenopausal, surgically sterile or otherwise incapable of pregnancy for at least 1 year; or must be using highly effective contraception for at least 90 days prior to treatment with KX2-391 Ointment Males who have not had a vasectomy must agree to use barrier contraception Participants who in the judgment of the Investigator, are in good general health Willing to avoid excessive sun exposure Able to comprehend and are willing to sign an informed consent form (ICF) Exclusion Criteria: Clinically atypical and/or rapidly changing AK lesions on the treatment area Malignancy within 5 years prior to Screening except basal or squamous cell carcinoma not on the treatment area that were treated with curative intent and are without recurrence Used any of retinoids at the most 90 days before Visit 1 glucocorticosteroids and methotrexate or other anti-metabolites within, at the most 28 days, before Visit 1 Used any topical therapies, treatments, or surgical or destructive modalities on the treatment area within, at the most 90 days, before Visit 1 Currently, or has experienced cutaneous malignancy, sunburn or body art on the treatment area within, at the most 180 days, before Visit 1 A history of sensitivity and/or allergy to any of the ingredients in the study medication A skin disease or condition that, in the opinion of the Investigator, might interfere with the study conduct or evaluations, or which exposes the participant to an unacceptable risk by study participation Other significant uncontrolled or unstable medical diseases or conditions that, in the opinion of the Investigator, would expose the participant to unacceptable risk by study participation Females who are pregnant or nursing Participated in an investigational drug trial during which an investigational study medication was administered within 14 days or 5 half-lives of the investigational product, whichever is longer, before dosing.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jane Fang, MD
Organizational Affiliation
Kinex Pharmaceuticals Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Center for Dermatology Clinical Research
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
eStudy Site
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Palmtree Clinical Research, Inc.
City
Palm Springs
State/Province
California
ZIP/Postal Code
92262
Country
United States
Facility Name
Horizons Clinical Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Clinical Research of South Florida
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
International Dermatology Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Compass Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Forward Clinical Trials, Inc.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33624
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Minnesota Clinical Study Center
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Dermatology and Laser Center of Charleston
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Institute of Clinical Research - Tennessee, LLC
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37130
Country
United States
Facility Name
J&S Studies, Inc.
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
The Center for Skin Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Dermatology Clinical Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33196758
Citation
Kempers S, DuBois J, Forman S, Poon A, Cutler E, Wang H, Cutler D, Fang J, Kwan R. Tirbanibulin Ointment 1% as a Novel Treatment for Actinic Keratosis: Phase 1 and 2 Results. J Drugs Dermatol. 2020 Nov 1;19(11):1093-1100. doi: 10.36849/JDD.2020.5576.
Results Reference
derived

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Activity & Safety Study of KX2-391 Ointment in Participants With Actinic Keratosis on the Face or Scalp

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